All posts in category FDA

Trifexis is a popular monthly oral medication for dogs that kills fleas, heartworms, roundworms, whipworms and hookworms. It also reportedly kills dogs.

When an investigative reporter from WSB-TV in Atlanta requested information on dog owner complaints from the company that makes Trifexis and was repeatedly refused, he filed a FOIA request with the Food and Drug Administration. The information he received is astonishing:

According to FDA records, pet owners have reported 700 dog deaths. That’s 120 more than the deaths linked to Chinese chicken jerky treats. Like the treats, Trifexis is suspected, but not the proven cause.

[…]

The FDA numbers also showed 259 of the 700 dogs that died were euthanized.

[…]

The new numbers also show a huge jump in the cases of dogs reported sick after taking Trifexis.

The WSB-TV piece points out that while Trifexis is outright hiding the numbers from the media, the FDA website is also woefully behind on updating its numbers. In other words, consumers who haven’t filed a FOIA request with the FDA themselves and didn’t see the WSB-TV report are most likely unaware of the seriousness of the owner-reported illnesses and deaths linked to Trifexis.

Heartworm medication is important and no one should disavow its use entirely based on this report. But consumer access to accurate information is also important in order to make informed decisions. If you are using Trifexis and concerned about the manufacturer hiding the number of owner-reported illnesses and deaths, talk to your vet about one of the many alternative heartworm drugs available.

Basically, I was left with a strong feeling of distrust after learning about the widespread pet food industry practices which resulted in the deaths and tragic illnesses of thousands of pets in this country. That feeling remains as strong as ever because the pet food companies didn’t say, “This is unacceptable! We’re going to do a complete overhaul and come back with new, transparent practices that will restore consumer confidence.” Far from it. What they said was more along the lines of, “Circle the wagons boys! Consumers are daring to ask questions. Screw that!”

As far as I know, not one significant thing in the practices of the pet food industry as a whole has changed for the better since all those pets suffered and died. Therefore, the potential for a recurrence is plausible to my mind. And indeed, we have regularly seen pet food products recalled, though on a smaller scale, in the years since. Granted, recalls are going to happen, but the reasons that they happen and how they are handled by the pet food companies are very similar to 2007. There have been a few isolated cases where I thought recalls were handled well – for example Orijen – but the large corporations still deny problems, rely on secrecy and employ the “proprietary information“, duck and cover business model.

Overall, I would say my opinion of pet food corporations has changed little since 2007. How about you – do you feel things in the pet food industry are better, worse or about the same?

[…]I wonder whether people who invest in high-end pet foods are getting their money’s worth. Are their pets really healthier and happier? Do they live longer? And are these foods any better than the generic versions sold in supermarkets and big-box stores?

The NYT piece contains an interview with food expert Marion Nestle, as does this piece in the San Francisco Chronicle.

A Veterinarian links the 2007 pet food recall to food safety issues which affect us all

FDA launches a pilot program for GRAS (Generally Recognized as Safe) “substances” in animal food. Let me guess, that would include everything on the planet?

Bravo, a company which sells raw pet food, is moving its production of beef and lamb formulas from the U.S. to New Zealand. Bravo had previously sourced some lamb and beef parts from New Zealand but did the manufacturing of the product in the States. One reason for the switch:

Sourcing and manufacturing the products in New Zealand enables Bravo to use the entire carcass and reduce the number of steps involved in the production process, thus resulting in better quality products[…]

I always like the idea of using an entire carcass of a food animal. I hate to think that anything edible or usable is wasted.

Usually I’m torn between slamming the FDA for their failure to protect consumers in favor of protecting corporations and decrying their inadequate resources to get the job done. Today though, I’m definitely on the former.

For one thing, I watched Food Inc on PBS last night. I actually only watched the first hour because I couldn’t take any more. I’ll go back for the second hour when I’ve gotten my strength back. Suffice to say the documentary is a graphic reminder that the government agencies mandated to keep our food supply safe are falling down on the job.

For another, FDA is using its scant resources to bring down the hammer on compounding pharmacies – which is an overreaction and a waste of taxpayer money in my view.

And finally, although the FDA did very little during the massive 2007 pet food recalls besides continually tell the public to buy corporate pet food because it’s perfectly safe and you can’t feed your pet on your own, they have now issued a consumer update warning dog owners not to feed bones:

The idea that it’s natural for dogs to chew on bones is a popular one. However, it’s a dangerous practice and can cause serious injury to your pet.

It continues on about how bones may puncture the stomach, get lodged in the intestines, break teeth, etc. A Veterinarian is quoted as follows:

“There are many bone-like products made with materials that are safe for dogs to chew on.”

Right. Probably ones that your Vet sells even. But that’s a total coincidence.

Shame on FDA for making no mention of the differences between raw and cooked bones. And shame on FDA for leading consumers to believe that the exact same warnings they give about feeding bones don’t also apply to dogs chewing “bone-like products”. And finally, shame on FDA for perpetuating their beloved myth that it takes a rocket scientist to know how to feed a dog and the general pet owning public is too dumb to ever figure it out.

Trust the professionals, do not try feeding your pet real food, you might kill him. Also, pay no attention to the man behind the curtain.

The most popular post on my blog right now seems to be this one from a year ago about the FDA telling Evanger’s pet food company to get it together on the botulism thing (I paraphrase, heh). So an update is probably in order. Apparently Evanger’s has not made satisfactory changes and the FDA (a government org which, inexplicably, lacks the authority to mandate recalls of anything but baby milk) has recently, in effect, shut the company down:

When the FDA announced its latest enforcement against Evanger’s, the agency’s Dr. Bernette Dunham said: “The FDA is stopping Evanger’s ability to ship pet food in interstate commerce. Today’s enforcement action sends a strong message to manufacturers of pet food that we will take whatever action necessary to keep unsafe products from reaching consumers.”

Before Evanger’s can resume shipping products, the FDA said, it must prove that corrective actions and processing procedures have been made to ensure the company’s finished product will not present a health hazard.

Botulism is a toxin that affects the nervous system and can be fatal, the FDA said. Symptoms of botulism in dogs and cat include progressive muscle paralysis, disturbed vision, trouble chewing and swallowing, and progressive weakness to the body. Death is usually caused by paralysis of the heart or the muscles used in breathing.

Even I know botulism=bad. So why can’t Evanger’s get it together after a YEAR? For their part, Evanger’s still seems to be saying it’s a paperwork snafu. Even if we were to grant that it’s some kind of clerical error, the fact that they haven’t been able to fix it to the FDA’s satisfaction over the course of 13 months just doesn’t look good.

U.S. Marshals seized millions of dollars worth of ingredients on May 7 2009 from American Mercantile Corporation, based in Memphis Tennessee. During an inspection of the company in March, FDA investigators discovered evidence of extensive rodent and insect infestation throughout the company’s warehouse, which the company failed to correct.

American Mercantile stores and processes food ingredients, which are sold or used in the dietary supplements, food, tea and pet food manufacturing industries.[…]American Mercantile apparently also has links to pet and equine foods. According to a story on herbs4horses.com, American Mercantile is a parent company of Herbs for Horses, an herbal product company for the equine and pet market. American Mercantile’s ability to source ingredients for equine and pet foods is what attracted Don Silver, Manager of Equine Science to sell his company to American Mercantile in 2006.[…]No one at Ingredients Corporation of America or Herbs for Horses was available for comment at the time of publication, but the ownership affiliation between these two companies and American Mercantile gives rise to the question about whether contaminated ingredients are in finished foods and pet products.

Based upon past recalls involving the contaminant melamine and the recent contaminated peanut product recall, we know that some ingredients are spread throughout the human and pet food market in a large scale manner. While we don’t know yet how widespread the use of these seized ingredients may be, I think it’s probably worth following the story to see what develops.

1. We now know that such diverse brands as Little Debbie, Keebler, Nutri System and Kashi all use the same ingredients (at least as far as peanut butter goes, maybe more). But wait a minute here – I thought if I paid more, I was getting a higher quality product? *sounds buzzer* Sorry, thanks for playing.

2. You can check a product’s website one day and it has an announcement reassuring consumers that their foods are safe. But the next day: recall! Are we supposed to believe the company didn’t know they were using the contaminated peanut butter from the mildew plant yesterday? Come on!

3. If you ask a company why only certain lots are being recalled (when presumably the other lots contain the same ingredients, at least they say so on the label) and if they’ve switched peanut butter vendors, they can’t give out specifics – it’s “proprietary info”.

4. Non-PB products that were processed on the same equipment as the recalled products now have to be recalled due to cross-contamination because apparently they don’t clean the lines between runs!

5. The Salmonella/Mildew peanut processing plant “lab shopped” until it got the “right” results on its food safety tests. Those records only have to be made available to the FDA after people start dying from their greedy scheme.

Gee, PB recall and 2007 Pet Food Recall – you guys are like twins. Let’s hope there isn’t a triplet happening out there right now which we will only be made aware of after people start dying.

Related:

Science Friday discussed the sad state of affairs at the FDA as part of the show today.

In case you haven’t heard, it seems like a long list of processed foods containing peanut butter as an ingredient (crackers, ice cream, dog treats, etc.) are being recalled due to Salmonella contamination. From the FDA:

Peanut Corporation of America (PCA), is expanding the recall of peanut butter and voluntarily recalling peanut paste made at its Blakely, Georgia facility because the products have the potential to be contaminated with Salmonella.[…]The recalled peanut butter and peanut paste were distributed to institutions, food service industries, and private label food companies in 24 states, the province of Saskatchewan in Canada, Korea and Haiti. The U.S. states are the following: Arkansas, California, Colorado, Florida, Georgia, Illinois, Indiana, Iowa, Maryland, Michigan, Minnesota, Missouri, Nevada, New Hampshire, New Jersey, New York, North Carolina, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, Utah and Virginia. In addition, affected product was used as an ingredient in other products that may have been distributed in other states.

None of the peanut butter being recalled is sold directly to consumers through retail stores by PCA.

PCA is not the only peanut butter manufacturer involved in this recall so you might like to take a look at all the recent FDA alerts. For now, they are saying that regular peanut butter on your grocery store shelf is not affected. As someone who eats a lot of peanut butter, I hope they are telling us the whole story.

Nothing says I Love You like a sweet teddy bear stuffy holding some delicious chocolate. Unless that’s [insert scary music here] MELA-CHOCOLATE! From the FDA:

Walgreens is recalling 173 teddy bears with chocolate bars sold in stores since late September 2008. Analysis by the U.S. Food and Drug Administration found that certain samples of the chocolate provided with the teddy bears were contaminated with melamine.

I guess those samples must have contained more melamine than the FDA (now) says it’s A-OK for us to eat. Gee, if only some way, somehow, the FDA could have had some kind of heads up on this whole melamine issue before it hit our food supply.

Thanks for the stuffed bear but as for the chocolate, make mine Labrador please.

Never fear: the FDA SWAT team is on da job. That’s right, just when you were worried that eggs, baby formula, and other milk products were contaminated with the same toxins which killed thousands of pets in 2007, the FDA swoops in to save us all from the menace of [insert JAWS theme here] PET TURTLES:

On March 3, 2008, Strictly Reptiles Inc., a wildlife dealer in Hollywood, Fla., sold 1,000 baby yellow-bellied sliders and Mississippi map turtles to a souvenir shop in Panama City, Fla. The sale violated a Food and Drug Administration (FDA) ban on small pet turtles designed to protect the public from the disease-causing bacteria Salmonella. Turtles often carry Salmonella on their outer skin and shell surfaces, and people can get Salmonella infection by coming in contact with turtles or their habitats.

On July 14, 2008, the U.S. District Court in Fort Lauderdale convicted and sentenced Strictly Reptiles for its role in illegally selling, and offering for sale, live undersized turtles. The Florida District of FDA’s law enforcement arm, the Office of Criminal Investigations (OCI), and the U.S. Fish and Wildlife Service investigated the case leading to the conviction, with help from FDA’s Center for Veterinary Medicine.

OK well I guess the melamine contamination is not such a worry after all. In fact, the FDA has flip-flopped on the whole melamine safety issue. When we learned about the toxin being in pet food last year, the FDA said it had “no approved use in human or animal food in the United States” and there was no safe level of melamine in foods. I’m a layman but this made sense to me since melamine is the material they use to make things like dinnerware and the Magic Eraser. But after discovering melamine and cyanuric acid in human foods this Fall, the FDA created a safety level for the poisons, except for baby milk. Now in an Olympic medal worthy double flip-flop, the FDA has determined safe levels of melamine and cyanuric acid for baby formula. I’ll have one Magic Eraser on an edible melamine plate TO GO and give me a kiddie meal of cyanuric acid on the side please.

But regarding the super-dee-duper dangerous pet turtles, the FDA really had to take a stand. Some things are too important to let slide (little turtle pun there – you’re welcome). See, the FDA warns us:

Small pet turtles are of particular concern because children are more prone to handling the turtles without washing their hands afterwards, and even putting the turtles in their mouths.

OK I admit I didn’t have a pet turtle as a kid. So perhaps it’s not surprising to learn that I never put one in my mouth. I do remember having a mouse and surely at some point I put him in my mouth but apparently that memory has been blocked. But one thing I do recall trying is dog food. In fact, I think I tried it because all the other kids I knew had tried it and I didn’t want to lose my status in the Nerd Society. Maybe you or your kid has put dog biscuits or cat food or dog kibble in their mouths too. Well I’m afraid I’ve got some bad news, May 2008:

A salmonella outbreak that swept 19 U.S. states in late 2006 has been a mystery, until now.

Nearly 200 consumers were sickened by what investigators believed to be tainted tomatoes, or other produce.

But now, the Centers for Disease Control says the apparent source of the 2006 salmonella outbreak was tainted dog food.

[P]et food is being voluntarily recalled because of potential contamination with Salmonella serotypeSchwarzengrund.[…]Salmonella can cause serious infections in dogs and cats, and, if there is cross contamination caused by handling of the pet food, in people as well, especially children, the aged, and people with compromised immune systems.

Mars Petcare US is extending a recall of dry pet food after the U.S. Food and Drug Administration (FDA) reported finding Salmonella in additional samples of the company’s SPECIAL KITTY Gourmet Blend cat food.

The earlier recall, issued October 27, was for cat food produced at Mars’ Allenton, Pa., plant on August 11, 2008. The recall is now being extended to cover all dry pet food produced at the plant with a “best by” date between August 11, 2009 and October 3, 2009.

Holy Bad Bacteria Batman – this is starting to look like a pattern! The FDA SWAT team response to all these Salmonella pet food issues? *crickets*

But before we judge the FDA too harshly for apparently protecting big business over American citizens, let us not forget their swift and decisive take down action on the pet turtle threat. I think we’ll all sleep a little better knowing that there are some safety issues that really bring the FDA out of their shells. (You’re welcome, redux.)